Histocell leads ITEAS project: industrial research to boost advanced therapies in the Basque Country

The ITEAS project investigates advanced therapy drugs to generate new therapeutic strategies for their application in complex diseases and to improve the quality of life during the aging process.

Advanced therapies are a new generation of innovative drugs with great therapeutic potential, ranging from the recovery of tissue or organ function, the treatment of inflammatory and autoimmune diseases, to their application in targeted therapies for degenerative and genetic diseases. The European Medicines Agency classifies advanced therapy medicinal products (ATMPs) into three main types: 1) Gene therapy: with recombinant genes for the treatment of genetic alterations, degenerative diseases or even some types of cancers; 2) Somatic cell therapy: to activate repair processes or act in the immunomodulation of the inflammatory system; 3) Tissue engineering: with the objective of repairing, regenerating or replacing injured tissue. These different ATMPs can be combined with medical devices (combined ATMPs) such as different types of polymers, proteins or extracellular matrix derivatives forming three-dimensional structures that allow, among other functions, to improve the mechanical properties of the drug or its biodegradation rate.

Advanced therapies are in a situation of extensive clinical development in various pathologies in which there are unresolved medical needs and have become a reality in the medical field. In addition, technological advances in the various areas of science, medicine and engineering are making it possible to work together in the development of new delivery systems, to provide therapies specifically directed to the target tissue or cells, or to obtain structures that increasingly better simulate the natural structure of tissues (3D printing). At the moment, few ATMPs are authorized and in the marketing phase, since they are innovative technologies that involve, apart from the lengthy clinical development required as drugs for human use, a great deal of prior work in the areas of manufacturing, scale-up and the definition of logistics, in order to preserve the drug’s activity,
especially when they are composed of viable cells. Given the therapeutic potential of these drugs, the European Union has decided to become an active player for economic growth in a research- and innovation-intensive sector such as biotechnology. In addition, the ATMPs market is expected to reach $21.2 billion by 2028, expanding at a CAGR of 13.2 % between 2021 and 2028.

In view of this situation, there is a need for a large-scale, focused and determined research initiative to create a true space for Research in Advanced Therapies. This is demonstrated by the commitment of the European Union (Horizon Future 2021-2027 and NextGeneration funds); by the Spanish Government with PERTE Salud de Vanguardia, which promotes development and research in Advanced Therapies; and by the Basque Government, which has launched the strategic proposal BAT (Basque Advanced Therapies) as a candidate to apply for Next Generation EU recovery funds. The Basque Country also has research groups of excellence in this field and pioneering companies with products, capacity and interests in this sector.
ITEAS Project, research in advanced therapies for the resolution of unresolved medical needs.
The objective of the ITEAS project is to establish a sustainable Basque ecosystem that integrates transdisciplinary research, clinical centers, the pharmaceutical and technology industry, regulatory bodies, patients and public society to overcome the technological and regulatory obstacles to the implementation of an industry based on Advanced Therapies. The proposal for the generation of new knowledge and new technological developments in the ITEAS project focuses on ATMPs products for cellular, tissue and combined therapy, their processing and monitoring sensor systems.
ITEAS is a strategic industrial research project that has received funding from the Hazitek 2022 program, a business R&D support program of the Basque Government’s Department of Economic Development, Sustainability and Environment, co-financed by the European Regional Development Fund (Feder).

The consortium, led by HISTOCELL, is composed of 10 industrial partners. The participating companies are DOMOTEK, EKOLBER, GRAPHENEA, IMG PHARMA BIOTECH, MEPRO, POLIMERBIO, TECBIOCEL, TECNALIA CERTIFICACIÓN and UNIKARE BIOSCIENCE; and it has the collaboration of 8 agents of the Basque Network of Science, Technology and Innovation that have participated in a large number of oriented basic research projects, whose results will be applied in this project. These agents are 5 technology centers (TECNALIA, CIC Biogune, CIC Biomagune, GAIKER and POLYMAT), a health research institute (IIS Biodonostia), 5 research groups of the UPV/EHU (NanoBioCel, Signaling Lab, Zibio Group, Biomat and Physiology) and a business R&D unit (Hispavista Labs).

The advances of ITEAS will allow, in a direct way, the growth of the industry based on Advanced Therapies and complementary technologies, promoting a more competitive Basque industrial fabric, and a greater knowledge and offer in R&D, providing relevant solutions in the value chain of the Health industry, of special interest for the Basque Health Cluster.